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FDA 510(k)

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM

K-Number: K971840 · 1998-03-04

ApplicantInvivo Research, Inc.
Decision Date1998-03-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research, Inc.. It received FDA 510(k) clearance on 1998-03-04 under 510(k) number K971840. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM?

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-04. The listed applicant is Invivo Research, Inc.. The 510(k) number is K971840.

When did OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 1998-03-04, under 510(k) number K971840.

Who is the listed applicant for OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM?

The FDA 510(k) record lists Invivo Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM?

The FDA product code for OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM is MHX.

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Other records listing Invivo Research, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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